Needleless connector

ABSTRACT

A needless connector is provided which utilizes a resealable preslit septum valve. The valve is resiliently restrained relative to a housing with the valve and housing configured to accept a standard male luer lock having a luer tip which penetrates the valve through the opening to extend within the housing and a luer locking flange of the luer lock extending about the housing. The valve includes a disk shaped upper portion covering the opening, a lower portion spaced from the housing and extending downward from the disk shaped portion into a passageway defined by the housing, and an annular skirt to attach the septum to the housing. The connector exhibits satisfactory leak pressure after multiple connections and disconnects to the luer lock fitting and long periods of indwell of the luer tip.

This application is a continuation of application Ser. No. 09/081728,filed May 20, 1998 now U.S. Pat. No. 5,957,898, issued Sep. 28, 1999,claims the benefit of U.S. Provisional Application No. 60/047,161, filedMay 20, 1997.

FIELD OF THE INVENTION

The present invention relates generally to needleless fluid connectiondevices and more specifically to a device for repeatedly establishing asealed connection to a conduit or a container for medical applications.

BACKGROUND OF THE INVENTION

One very prevalent form of health care therapy is infusion orintravenous (“I.V.”) therapy whereby fluids possessing desiredmedication or other characteristics are infused into a patient overvarying lengths of time. To practice this infusion therapy frequently aconnection needs to be made between components for the transfer of fluidbetween the two components, along a fluid passageway and eventually to apatient. As an example, administration sets are widely used toadminister liquids parenterally to a patient and other medical devicesare connected to the administration set to provide the properadministration.

One widely used connector for making a connection between medicaldevices to establish a fluid passageway is a luer connection assembly.In the luer connection assembly, a male luer tip component or fittinghaving a frustoconical shape is inserted into a female luer component orfitting having a frustoconical shaped receiving cavity and opposingconical surfaces come into contact to form a sealed friction fit.

Until the connection is made, the passageway through each of the luerfittings and into the lumen of a component attached to the luer fittingis open to the environment. This lumen and the passageway through theluer connectors form a portion of the fluid passageway and must besterile prior to use and then sealed against microbial ingress duringuse. Thus, these connection assemblies and the associated components arepackaged in sterile packaging and the connections are typically madejust prior to establishing fluid communication with a patient's venoussystem.

There are two general types of luer connection assemblies. One type isgenerally referred to as the luer slip where the connection ismaintained by the friction fit between the male luer tip and female luercomponent. The other type is generally referred to as a luer lockconnection whereby the male luer tip is encircled by an annular flangehaving a threaded internal surface. The female component includes acorresponding thread formed about the outer surface. Engaging thethreaded flange to the threaded outside surface establishes theconnection between the male luer tip and female component whilepreventing accidental disconnects.

To insure a universal luer connections among components provided by amultitude of manufacturers, luer connection assemblies are manufacturedto comply with universal standards. Very important sets of standardssuch as ANSI and ISO standards. These standards includes standarddimensions for male slip and luer lock assemblies. Among thesedimensional standards are standards which define the spacing orclearance between the annular locking flange and the male luer tip. Thusany female connection device configured to establish a connection to astandard male luer lock must be able to engage the luer tip and lockingflange within this clearance or spacing.

Other standards in the ISO standards include several performancerequirements for luer connections. One such requirement is that after aluer lock type connection is made, to prevent inadvertent disconnection,the luer connection should resist an axial removal force of 8 pounds andunscrewing torque less than 2.8 in/oz without disconnection. Luerconnections should also hold a seal against 45 psi after a connectiontorque of 16 in/oz has been applied. In standard luer connections thisresistance and sealing is supplied by the friction between the opposingconical surfaces.

Once a component of I.V. therapy is placed in fluid communication withthe body, the fluid passageway should be sealed from the environment toprevent contamination and this passageway should also be sealed so as tonot allow any leakage of bodily fluids into the environment. However,most therapies require periodic access to the fluid passageway. Becausethe portion of the fluid passageway through a female luer connectioncomponent is open to the environment, these components will not form asealed connection to the fluid passageway after the fluid passageway isplaced in fluid communication with the body.

In one prevalent example of intravenous therapy, fluid containing a drugin solution is injected into a primary flow of fluid from an I.V.solution container through an administration set to a catheter extendingwithin a vein. The drug containing fluid may be injected from a syringe,secondary medication set or the like, into the set where it mixes withthe flowing fluid. In another prevalent example, fluid is injecteddirectly into or withdrawn from a catheter extending within the body. Inaddition the catheters are flushed periodically to maintain patency bythe injection of small amounts of saline or heparin.

As can be appreciated, it is highly desirable to maintain catheters andadministration sets in service as long as possible without compromisingthe safety of the patient. Replacement of catheters and sets is timeconsuming and expensive. Therefore over the period of time of use of aset or catheter there may be many connections and disconnects. Forexample, there may be over 100 connections and disconnects to aconnection site on a catheter or set before the catheter or set isreplaced. In addition a connection may be made and that connectionmaintained for an extended period of time before disconnection. Forexample a connection may be made for up to seven days of “indwell” andyet the connection should still be capable of accepting intermediate andsubsequent connections and disconnects without allowing leakage to theenvironment.

Another highly desirable attribute of a connector is the ability forsuch a connector to seal against pressurized fluid found within a set orfor the connector to possess a certain leak pressure in excess of adesired pressure. For example it is desirable for a connector to have aleak pressure which is in excess of 20 p.s.i. for a short period of timesuch as when a bolus administration of drug is injected into a set and aleak pressure in excess of 6 p.s.i. of continuous pressure duringinfusion of medication.

In addition, a connector may be exposed to negative pressureparticularly when such connector is located upstream of an inlet of anintravenous pump. Failure to prevent aspiration through a connector whenthe connector is exposed to negative pressure may lead to an aspirationof air and/or microbes into the fluid passageway.

Depending on the application, many other features may be desirable. Deadspaces within any connector which cannot be “flushed” should beminimized or eliminated as they may form an environment for microbialgrowth. Also, priming volume for the connector should be minimized.

Because intravenous therapy is practiced on a worldwide basis andmillions of connection sites are used every year and the costs ofcomponents used in such therapy are a factor in the cost of therapy, anydesired connector should be capable of being manufactured at high speedsand low cost. Generally the lower the number of parts making up acomponent, the lower the number of molds and high speed assembly devicesboth of which generally translate to lower capital expenditures andtherefore lower costs.

On the other hand, whatever the connector configuration, it is highlydesirable that the connector be capable of low defect manufacture. Evena small number of failure is generally unacceptable when a singlefailure may put a patient or health care provider at risk.

Moreover, it is also highly desirable that any surfaces around an inletinto a connector be able to be swabbed or otherwise disinfected.Typically unbroken or smooth surfaces facilitate swabbing and otherdisinfecting techniques.

As mentioned previously, although luer connectors are widely found inthe medical environment such connections are generally not acceptablewhen many of the above described requirements need to be satisfied. Thisis primarily due to the fact that the opening through the luer connectoris not sealed so that upon disconnection the opening and the fluidpassageway are open to the environment which would pose a health hazardto the patient.

Another factor which prevents use of luer connection assemblies inadministration sets or injection sites is the inability for such aconnector to seal against the pressurized fluid found within a setunless that connector is sealed or connected to a mating connector. Theopening in a luer fitting will obviously allow such a pressurized fluidto leak.

To allow the sealed connections and disconnects to a fluid passagewayextending in a set or catheter, on many sets there are one or moreinjection sites having a solid resilient septum in a housing are placedon the set or catheter. A sharpened needle is used to penetrate theseptum to provide a connection to the fluid passageway. Although suchconnections possess many of the desired characteristics for sealedconnections, the sharpened needles poses a needlestick hazard.

To combat the needlestick hazard, one embodiment of a needleless systemshas been developed which utilizes a resealable septum formed with a slitand compressed within a housing. These needleless systems performedquite well; however, the septum can not be penetrated with a male luertip and thus a blunt cannula is utilized having a diameter smaller thana male luer tip. If the device to which a connection needs to be madehas a luer connector, these blunt cannula are generally attached to theluer fitting. The requirement of the blunt cannula potentially increasesthe costs of using these types of connectors.

Another type of needleless systems use connectors which are constructedto establish a connection directly with the male luer tip whether suchluer tip forms a part of a luer slip or a luer lock. However connectionswhich are to be established with a male luer tip in a manner similar toa luer lock connection described above must be capable of fitting withinthe standard spacing between a luer tip and locking flange and shouldalso meet other standards which have been set out for such connections.

Examples of these systems'connectors to establish a connection directlywith a male luer tip are shown in U.S. Pat. No. 5,685,866, thedisclosure of which is incorporated by reference herein. Theseconnectors appear to all possess shortcomings which hinder widespreadacceptance by medical practitioners. In general, all of these devicesperform in an inferior manner when measured relative to the desirablequalities for connector devices discussed above and also in comparisonto the performance standards of a injection site for a sharpened needleand resilient septum or a blunt cannula and pre-slit resilient septum

For example, several connectors utilize a resilient boot or other sealwhich is placed within a housing and collapsed by the introduction of amale luer tip. Upon removal of the tip, such collapsing boots must thenrecover to reseal the connection. Many or these boots stick in thecollapsed position which leads to leaking. In addition these movingparts present an interface between the movable boot and housing intowhich fluid may flow and collect and such collected fluids form afertile environment for microbial growth, and recessed surfaces and gapsare hard to disinfect. Moreover, the spikes act as flow restrictors andmay impart severe turbulence to fluid as it flows through the openingsin the spike. Furthermore, after withdrawal of a male luer tip the bootsmay not recover quickly enough to seal the entrance through theconnector and the fluid passageway may be briefly exposed to theenvironment.

One type of such luer tip connectors has a spike within the housingwhich penetrates a collapsing boot. The spike has openings proximate anend adjacent the boot and form an internal passageway for the flow offluid which is opened when the spike penetrates the collapsed boot andspreads the slit. Upon recovery, any slit or opening in the boot mustreseal. However, the spike design has exhibited unsatisfactory leakageafter a number of connects and disconnects which does not provide forextended use of a set or catheter.

In addition, these connectors have a multitude of parts which increasesmanufacturing costs and opportunities for malfunction. These designsalso produce a connector having voids which cannot be flushed such thatstagnant fluid may collect. Moreover, several of these device havepotential passageways from voids within the housing but outside theprimary fluid passageway, into the primary fluid passageway which mayallow any microbial growth within the housing to enter the fluidpassageway. Also the interface between the housing and boot is difficultto swab when the boot is in the uncompressed position.

A device described in U.S. Pat. No. 5,616,130, the disclosure of whichis incorporated by reference herein, utilizes an elongated cam to spreadopen a slit in a collapsing boot, and would appear to possess several ofthe shortcomings of the spike and boot designs described above.

It is generally not a problem for the boot connectors to have ends whichengage the male tip and locking flange on a standard luer lock. Thesealing mechanism is below the end of the luer tip when the tip isengaged to the connector, thus there Is a large amount of flexibility inthe configuration of the end of the connector housing which engages themale luer lock.

To overcome many of these deficiencies, needleless connections whichutilize a preslit septum as one of the components were developed. Theseconnectors establish a connection with the penetration of the slit inthe septum by the luer tip. One such connector is shown and described inU.S. Pat. No. 5,578,059, the disclosure of which is incorporated byreference herein. In the disclosed valve, a resilient preslit septum isutilized to form an environmental barrier. The septum is sealinglycaptured or held to the housing by having a lower flange which ispinched between a retainer and housing. It appears that the radiallyextending portion having a slit is maintained in position by the columnstrength of an outer axially extending cylindrical portion extendingupward from the lower flange. However the septum appears not to becapable of sealing against the pressurized fluid found in a set. Thusthe valve uses a second lower check type valve to seal against thepressure.

To satisfy ISO dimensional standards and torque removal resistancestandards the outer portion of the retainer is formed with a taperedthreads so that the connection to a luer lock's straight thread designis similar to a standard NPTF/NPSI connection. The tapered thread designextends over the end of the housing that engages the threads on a maleluer lock. Such a thread design may produce too rapid an increase inengaging force during the connection which may lead to a lock up of theluer lock to the connector.

Such a device suffers from several other drawbacks. The valve includes anumber of components to make up the housing, the environmental valve andcheck valve, and this high number of components increases manufacturingcosts. In addition, maintaining the septum in position by the columnstrength of the axially extending portion of the septum forces thatportion to have a relatively large thickness. Thus for the septum, theaxially extending wall and surrounding housing to fit within theclearance between the luer tip and the locking flange upon penetrationof a male luer tip to a desired depth, the housing must be thinned. Sucha thinned housing may fracture upon repeated connections anddisconnects.

A second connector is described in U.S. Pat. No. 5,533,708, thedisclosure of which is incorporated by reference herein. This connectoralso utilizes a preslit septum which is supported on an axiallyextending column having sufficient thickness to support the septum uponintroduction of the male luer tip. The further provide sufficient columnstrength the axially extending portion is also formed with a specifictapered shape including a thickened lower portion. To seal the slitduring introduction and removal of a luer tip, the underside of thepre-slit radial portion of the septum is formed with biasing ribs.

This connector also uses a retainer which pinches a lower radial flangeto sealingly fix the septum to the housing. Thus the connector includesthree separate pieces. In addition the thickened axially extendingportion of the septum forces the retainer to be thinned such that topresumably supply strength to the retainer the stated preferred materialfor the retainer is metal which increases manufacturing costs. Inaddition it is believed that such valves will not exhibit satisfactoryleak pressure after long periods of indwell, likely due to compressionset of the septum material due to a perceived high level of compressionof the septum material between the tip and retainer.

To supply the necessary unscrewing resistance, the retainer is taperedoutward proximate the end to establish a frictional engagement with thethreads on a male luer lock.

Another feature which is desired by some users, is that a connector notsiphon fluid from an attached tubing or catheter into the connector uponremoval of the luer tip as this may cause fluid to flow into the otherend of the catheter which it is felt may lead to blockage of the tubing.In addition it is desired that a connector is provided which actuallyexpels fluid from the connector upon removal of the luer tip andpreferably expels such fluid in a controlled manner.

Therefore, it is a main object of the invention to overcome thosedisadvantages of the prior art which prevent widespread acceptance ofneedleless valves which do not require a blunt cannula.

There are other secondary objects, one or more if satisfied may promotemarket acceptance but satisfaction of each may not be necessary. Oneobject of the present invention is to provide a needless connectorfitting which may be actuated by a male luer tip without using asharpened needle or an adapter such as a blunt cannula or the like. Arelated object is to provide a connector which may engage a standardluer lock fitting. A further related object is to provide such aconnector which may be coupled to a standard male luer lock and compliesas much as possible with ISO and ANSI standards for luer connectors

Another object of the present invention is to provide a connector whichpossess sufficient strength to avoid cracking or fracture.

It is a further object of the present invention to provide a connectordevice which utilizes a minimum number of parts and therefore minimizesopportunity for malfunction.

It is another object of the present invention to provide a connectordevice which is capable of providing for a large number of connectionsand disconnects while maintaining the ability to seal against fluidsunder pressures typically found in an administration set. A relatedobject is to provide such a connector which is capable of providing aminimum of 100 connects and disconnects without compromising theperformance.

It is yet a further object of the present invention to provide aconnector which upon a disconnection, maintains a leak pressure of 6psi. constant pressure and 20 psi transient pressure after 4 days ofindwell.

It is a further object of the present invention to provide a connectorwhich is capable of high speed manufacturing. It is a related object ofthe present invention to provide a connector which may be manufacturedwith a very low number of potential defects.

It is yet another object of the present invention to provide a connectorwhich minimizes voids which cannot be flushed in which stagnant fluidcan collect to form a media for microbial growth. It is a related objectof the present invention to provide a connector which forms a sealedfluid path such that a minimum number of microbes enter the fluid pathduring operation using aseptic techniques. It is a further relatedobject to provide a connector which requires a low priming volume.

It is still a further object of the present invention to provide aconnector which minimizes or eliminates flow restrictions for the flowof fluid through the connector. In addition it is an object to provide aconnector having smooth unbroken surfaces about any inlet to facilitateaseptic techniques.

It is yet another object of the present invention to provide a connectorwhich forms a continuous closed system which seals the fluid passagewayfrom the environment during and after insertion of a male luer tip andinstantaneously after withdrawal of the luer tip.

It is a further object of the present invention to provide a connectorwhich does not siphon fluid into the connector from an attached medicaldevice upon removal of a luer tip. A related object is to provide aconnector which provides a flow of fluid from the connector during andpossibly after removal of the luer tip.

SUMMARY OF THE INVENTION

The above main object is satisfied by connector utilizing a resealablevalve having an opening extending through at least a portion of thevalve. The valve is resiliently restrained relative to a housing withthe valve and housing configured to accept a penetrating member having atip which penetrates the valve through the opening.

One or more of the secondary objects are satisfied by a valve uniquelyconfigured to seal against pressures typically found in fluidpassageways which are in fluid communication with the body. Preferablythe resealable valve is a septum and the septum and housing are uniquelyconfigured to accept male luer tips. In one embodiment, the septumincludes an upper generally disk shaped upper portion covering anopening defined by the housing and a portion extending downward from theupper portion with the valve opening extending through both the upperand lower portion.

The upper portion of the valve is resiliently retained relative to thehousing by integral attachment with an annular skirt and the skirt maybe attached to the interior surface of the housing in a first embodimentand surrounding and attached to an exterior surface of the housing in asecond embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a section view of a first embodiment of a needless connectorof the present invention;

FIG. 2 is a section view of the connector of FIG. 1, shown connected toa male luer tip;

FIG. 3 is a section view of a septum forming a part of the connector ofFIG. 1;

FIG. 3a is a bottom plan view of a septum forming a part of theconnector of FIG. 1;

FIG. 4 is a section view of a second embodiment of a needless connectorof the present invention;

FIG. 5 is a section view of a septum forming a part of the connector ofFIG. 4;

FIG. 5a is a bottom plan view of a septum forming a part of theconnector of FIG. 4;

FIG. 6 is a perspective view of the connector of FIG. 4;

FIG. 7 is a sectional view of a connector similar to the connector shownin FIG. 4 included as a part of a Y-site;

FIG. 8 is a third embodiment of the needleless connector of the presentinvention;

FIG. 9 is a section view of an alternate embodiment of a needlelessconnector of the present invention;

FIG. 10 is a section view of the connector of FIG. 9 shown connected toa male luer tip;

FIG. 11 is a section view of a further alternate embodiment of aneedleless connector of the present invention; and

FIG. 12 is a section view of the connector of FIG. 11 shown connected toa male luer tip;

FIG. 13 is a section view of a further alternate embodiment of aneedleless connector of the present invention;

FIG. 14 is a section view of the connector of FIG. 13 shown connected toa male luer tip;

FIG. 15 is a section view of a further alternate embodiment of aneedleless connector of the present invention; and

FIG. 16 is a section view of the connector of FIG. 15 shown connected toa male luer tip.

DETAILED DESCRIPTION

The following description is not intended to limit the claimed inventionto the described embodiments and the disclosed combination of featuresin the various embodiments might not be absolutely necessary for theinventive solution.

Referring to FIG. 1, a first embodiment of a connector device of thepresent invention is generally indicated at 10. The connector 10generally provides multiple fluid connections with a penetrating member12 (FIG. 2). In an example, the connector 10 may be attached to aconduit 14 in fluid communication with the human body. The conduit 14may be a peripheral catheter 15, medical tubing or the like and forminga passageway 16 in fluid communication with the body for the flow offluid to or from a body. The connector 10 may also be attached to otherdevices such as a vial or vial adapter (not shown) or the like or theconnector may be used in lieu of open female luer fittings such asfittings on stopcocks.

Referring to FIG. 2, in an example, the penetrating member 12 ispreferably a male luer slip or luer lock 13 conforming to ANSI or ISOstandards; however, examples of other members, with appropriatemodifications to the housing and septum, may include blunt cannula,needles, specially designed connectors or the like. The luer lock 13includes a luer tip 18 which, in the embodiment shown, is encircled by alocking flange 20 and forms the end of a syringe 24. Other devices whichmay utilize a penetrating member 12 include I.V. sets, blood collectionand peritoneal dialysis devices and the like.

Referring also to FIG. 1, the connector 10 includes a housing 26 and anelastic and resilient resealable member 27, preferably a septum 28,disposed at an upper end 30 of the housing to seal an opening 32 definedby the upper end 30. The septum 28 is operably connected to the housing26 with a central portion 34 elastically restrained relative to thehousing such that the central portion 34 may be stretched downward intothe housing as the penetrating member 12 is inserted into the opening.The central portion 34 elastically retracts upon removal of thepenetrating member 12. The housing 26 forms an axially extendingpassageway 36 which extends downward from the opening 32 and is in fluidcommunication with the lower passageway 16 defined by the conduit 14.The resealable member 27 is uniquely configured to seal the opening 32when the central portion 34 is in the occluding position shown in FIG.1.

The central portion 34 of the septum 28 has a generally disk shapedupper portion 38 and a lower portion 40 extending axially downwardwithin the passageway. A resealable opening 44, such as a slit 46extends downward preferably through both the upper portion 38 and lowerportion 40. It is anticipated that the opening 44 may be formed so thatinitially the opening may extend only through a portion of one or bothof the upper and lower portions 38, 40; however, extending a penetratingmember 12 completely through the septum 28 will force the opening toalso extend completely through the septum 28. Preferably the opening 44is configured in such a manner such that when the penetrating member 12extends completely through the septum 28 the upper and lower portions38, 40 are elastically stretched about the penetrating member to sealagainst leakage through the interface between the penetrating member andthe septum.

The slit length in the horizontal direction is preferably shorter thanone half the circumference of the tip end of the luer tip 18.

As shown in FIG. 3 and 3a, in the first embodiment, the lower portion 40forms a generally rectangular horizontal cross section. Verticallyextending sidewalls 48 and end walls 50 are slightly tapered so that thelower portion 40 forms a trapezoidal vertical cross section whichfacilitates molding and orienting the septum during manufacturingparticularly when forming an opening 44. The opening 44 may extendstraight downward or be oriented at an angle relative to the vertical.In addition, the opening 44 may be a slit 46 or may be curved orslightly helically rotated to promote the sealing of the opening.

Referring back to FIG. 1, the septum 28 includes an annular skirt 52which extends downward within the passageway 36 and is attached to theinner surface 54 of the housing 26 to elastically restrain the centralportion 34 relative to the housing. The attachment is preferably made byadhesively bonding an outer surface 56 of the skirt 52 to the innersurface 54. Because displacement of the central portion 34 into thepassageway 36 by the luer tip 18 (FIG. 2) applies shear stress to theattachment between the skirt 52 and housing 26, the septum 28 includes aradial lip 58 which extends over and is attached to an upper edge 60 ofthe housing. The attachment of the lip 58 and edge 60 at least partiallysupports the skirt 52 and aids in resisting the shear forces. In thefirst embodiment, the attachment between the lip 58 and edge 60 is by anadhesive bond in the same manner as the attachment of the housing andthe skirt 52.

Referring to FIG. 2, to insure universal connectivity, it is preferablethat dimensions of luer connecting devices are standardized to ISOstandards. For example, the dimensions of the luer tip 18 including thetaper are set by the standard. Similarly threads 64 on the inside of thelocking flange 20 define a clearance radius which is set by thestandard. As can be appreciated, when the male luer tip 18 extendswithin the connector 10 and the locking flange 20 extends about theexterior of the connector, the size of the connector and its componentsare constrained within the spacing between the luer tip and lockingflange. Also, according to ISO standards, the male luer tip 18 should beable to penetrate to a desired insertion depth “D” of 0.300 inches whichadditionally constrains the size of the connector 12 and its componentsparticularly about the upper end 30 of the housing 26 which must fitwithin the spacing between the luer tip 18 and locking flange 20.

In FIG. 2 the luer tip 18 is shown forcing the septum 28 into an openposition. In particular the tip 18 extends through the opening 44 to thedesired depth D, establishing fluid communication between a passageway66 in the tip 18 and the passageway 36. To minimize any flowrestriction, the passageway 36 adjacent the tip 12 is preferably open tothe passageway 16 without any secondary valves or other obstructions tofluid flow. The upper portion 38 of the septum 28 pivotally deformsdownward, stretches and extends along the annular skirt 52 and the outersurface 68 of tip. In addition the lower portion 40 of the septum 28extends downward and stretches about the outer surface 68, andestablishes a seal about the tip 18.

Referring briefly back to FIG. 1, upon removal of the tip 18, the septum28 resiliently retracts into its closed position.

When the tip 18 is inserted into the connector 10 to the desired depthD, there is a limited amount of annular space between the housing 26 andtip into which portions of the septum 28 may be displaced; however, theseptum must be configured and sized to seal before, during and afterextension of the penetrating member 12 through the opening 44 to form aclosed system.

Referring to FIGS. 1 and 2, in several applications in the medicalenvironment, it is highly desirable that connectors be configured toseal against a pressure of 20 psi. As noted above, in various connectordesigns using a pre-slit septum and blunt cannula penetrating member, asdescribed in U.S. Pat. No. 5,135,489, incorporated by reference herein,the sealing is accomplished by utilizing a thickened septum and ahousing to radially compress the septum thereby sealing a slit extendingthrough the septum. When a blunt cannula of small diameter is forcedthrough the slit, the septum is additionally radially compressed whichseals about the cannula, and there appears to be little displacement ofportions of the septum in an axial direction.

However, even if a luer tip 18, with its much wider diameter relative tothe housing opening than the blunt cannula relative to the correspondinghousing opening, could be forced through the slit in such a septum,there is little room in the radial direction to provide a receivingspace for the displaced mass of the septum. Thus, the necessaryinsertion force would likely be too much for most medical practitioners.However, it has been found that thinning the septum 28 to allowdisplacement and accommodation of the septum between the tip and housingwhile maintaining the same radial compression does not provide theseptum with the ability to seal against a pressure found in fluidpassageways i.e. “leak pressure”, found during intravenous therapy.Unexpectedly, increasing the radial compression of the thinned septumdoes not appear to provide a corresponding rate of increase in the leakpressure of the connector 10.

Forming the septum 28 with a thinned upper portion 38 and a downwardlyextending lower portion 40 and providing that the opening 44 extendsdownward through the lower portion 40 in addition to the upper portion38 greatly increases the leak pressure without requiring a correspondinglarge increase in septum thickness or compression. Moreover, tests haveshown that the length “L1” (FIG. 3) of the lower portion 40 is relatedto increasing the leak pressure. But, increasing the mass of the septum28 by increasing the length L1 of the lower portion 40 which must beaccommodated within the housing 26 when a luer tip 18 penetrates theresealing member 28, increases the insert force and could possiblyprevent the tip 18 from extending entirely through the opening 44.

The first embodiment's configuration of a unique combination with apredetermined length L1 of the lower portion 40, thickness andcompression of the upper portion 38 gives the connector 10 a leakpressure of more than 20 p.s.i while presenting an acceptable insertforce. Other features of the configuration of the first embodiment isthe ability to provide a reseal, after multiple insertions of the luertip and long periods of luer tip indwell, against a pressure of 6 p.s.i.

As an example, in the first embodiment, forming the septum with theupper portion 38 having a thickness of 0.040 inches and a 3.5% radialcompression or greater and the lower portion 40 having a length L1 ofabout 0.080 inches (giving rise to a opening length of 0.125 inches)yields a connector 10 which may accept the luer tip 18 to the desireddepth D while maintain a leak pressure in excess of 20 p.s.i.

Referring in particular to FIGS. 3 and 3a, preferably the lower portion38 is formed with a width “W1” of approximately 0.060 inches and alength “L2” of about 0.190 inches. The annular skirt 52 is formed with athickness of about 0.010 inches. The top surface 70 of the septum 28 isslightly concave to lessen the amount of material being forced into thehousing 26 upon insertion of the tip 18 through the opening 44. It isenvisioned that the top surface 70 may be flat or have a convex surfaceor a combination, also. In addition, the top surface 70 is formedunbroken without crevices or other pockets which facilitatesdisinfecting of the septum 28 with normal aseptic techniques such asswabbing. Also the septum 28 is formed so that the top surface extendscompletely over the upper end 30 of the housing to present a visuallyappealing top surface.

Referring back to FIG. 1, to be able to accommodate the standarddimensions of luer fittings, the housing 26 is configured to form apassageway having a diameter “D1” of 0.235 inches. To facilitateinsertion of the septum 28 during assembly, the upper end of thepassageway 36 is tapered outward so that a slightly larger diameter of0.250 inches is formed at the opening 32.

Referring to FIG. 2, as can be appreciated, inserting the tip 18 andcompressing the upper portion 38 and possibly the lower portion againstthe annular skirt 52 should produce a thickness layer of at least 0.050and 0.040 inches respectively. However, when inserting one embodiment ofa penetrating member 12 having standard luer dimensions to a desireddepth D of 0.300 inches should only provide an annular clearance of0.030 inches between the tip and housing 26. Unexpectedly, the elasticmaterial of the septum elongates upon stretching and deforms into thissmall clearance dimension, while not exhibiting too low a leak pressureafter long periods of indwell due to compression set of the septum 28.

Referring again to FIG. 3a, the lower portion 40 is formed with roundedcorners 74 to form a gap 77 between the lower portion and skirt 52. Therounding of the corners 74 allows the sidewalls 48 and slit 46 to be aslong as possible while still providing the gap between the lower portion40 and skirt 52. Attaching the sidewalls 48 to the skirt 52 withoutproviding a gap may contribute to unequal stretching and deformation ofthe lower portion 40 about the tip 18 during insertion of the tipresulting in leakage. To create the gap 77 the valve member 27 at thegap 77 has a vertical thickness less than the length L1 of the lowerportion. Preferably the gap 77 is formed such that the verticalthickness of the valve member 27 at the gap is equal to the thickness ofthe upper portion 38 of the septum 28.

At the juncture between the central portion 34 and skirt 52 a sharpcorner is formed which establishes a hinge point 78. The hinge point 78which extends about the housing for the entire circumference of theopening 32 also facilitates the flexing and deformation of the septum 28during insertion of the tip 18.

In an embodiment, the septum 28 is formed of a elastic, resilientmaterial provided by the West Company of Lionville, Pa. It isanticipated that lubricating the septum 28 should facilitate insertionof the luer tip 18. Such lubrication may be applied while forming theslit or by other means such as incorporating the lubrication into theseptum material or by applying lubricious coatings to the top surface.In a second embodiment, the septum 28 may be formed of a similarmaterial, such as chlorinated polyisoprene produced by Lexington Medicalof Rock Hill, S.C. In addition, the slit may be lubricated afterassembly of the housing and septum using silicon oil produced by DowCorning of Midland, Mich. The housing 26 is rigid and preferably formedof DN003 from Eastar of Kingsport, Tenn.

Although the housing 26 is shown as forming a luer connection 84 at alower end, the housing may also be formed as a part of any device intowhich is it desirable to establish a sealed connection such as theinjection arm of a Y-site 86 (FIG. 7), as an inlet on a stopcock ormanifold (not shown) or the like. In addition the lower end of thehousing 26 may be integrally formed with a catheter 15 with a guidewire(not shown) extending upward through the opening 44. Referring also toFIG. 6, particularly when used as an injection site for a catheter 15,the exterior of the housing 26 is formed with a number of longitudinallyextending indentations 86 which facilitate gripping of the connector 10.

Referring to FIG. 1, to provide for a threaded engagement with a lockingflange 20 the upper end 30 of the housing 26 may be formed with a pairof radially extending ears 88 configured to engage the threads 64.Referring to FIG. 4, alternately threads 90 may be formed on thatportion 92 of the housing 26 which will engage the threads 64 on theflange 20.

Preferably the housing 26 is molded as a single piece utilizing moldswith a large number of molding cavities to facilitate high speedmanufacturing operation. Similarly the valve member 27 is preferablyformed as a single piece in a high speed molding operation, and theshape of the lower portion 40 is particularly suited to register thevalve member 27 in a desired orientation for fashioning an opening 44therein.

Referring to FIGS. 4-6, a second embodiment of the needleless connectorof the present invention is generally indicated at 100 and isparticularly suited to a large number of connections and disconnectswith a standard male luer lock 13 (FIG. 2) without unacceptable leakage.In addition, elements in the second embodiment corresponding to elementsin the first embodiment 10 are labeled with the same reference number.

The connector 100 includes a housing 102 and an elastic and resilientresealable valve member 104 disposed at an upper end 106 of the housing.The valve member 104 includes the central portion 34 and lower portion44; however the valve member 104, preferably a septum 105, also includesan annular skirt portion 108 which extends about and surrounds an upperportion 110 of the housing 102 adjacent the upper end 106. Preferablythe skirt 108 is bonded to the exterior surface 112 in a specifiedmanner to attach the valve 104 to the housing 102 and elasticallyrestrain the central portion 34 during insertion of the luer tip 18(FIG. 2).

Referring to FIGS. 4, 5 and 5 a, it has been found that the manner inwhich the valve 104 is configured relative to and attached to thehousing 102 has an important effect on the ability of the connector 100to achieve the desired performance standards. Preferably the valve 104defines a circular annular receiving channel 118 between the centralportion 34 and the skirt 108. The upper end 106 of the housing 102 isreceived in the channel 118 and bonded to the valve 104 in a desiredmanner.

The central portion 34 is configured such that the upper edge portion106 applies a 6 to 7% compression on the central portion. To provideadequate reseal, it is desired that the upper portion 40 of the valve102 form a thickness of 0.60 to 0.50 inches and the lower portion definea length L3 of 0.080 inches.

Preferably the lower portion 40 is formed with a width “W2” ofapproximately 0.060 inches and a length “L4” of about 0.165 inches. Theannular skirt 108 is formed with a thickness of about 0.010 inches. Thetop surface 70 of the septum 28 is slightly concave to lessen the amountof material being forced into the housing 102 upon insertion of the tip18 (FIG. 2) through the opening 44. It is envisioned that the topsurface 70 may be flat or have a convex surface or a combination, and isadapted to disinfecting techniques such as swabbing.

At the interface between the central portion 34 and upper end 106 of thehousing 102, the valve member 104 forms a sharp corner and thereby formsa hinge point 78. Similar to the first embodiment 10, lower portion 40is spaced from the housing to form a gap 77.

It has been found that bonding an upper landing 117 defined by an upperedge 116 to the valve 104 and about the entire circumference of the ofthe upper edge is important in the ability of the connector 100 tomaintain a satisfactory leak pressure and increasingly important tomaintain the leak pressure after 100 or more connections anddisconnects. The bonding also anchors the septum 28 to the upper edgeand prevents a rubbing between the septum 28 and upper edge 116 as theseptum is elastically stretched during insertion of the tip 18.

Bonding between the exterior surface 112 and the inner surface of theskirt 108 is also important, but migration of any bonding agent to theinterface between the central portion 34 and housing 102 should beminimized. If adhesive collects in the interface about the septum 28 andinterior surface 119 cracking of the housing 102 or compression set ofthe septum 28 with corresponding leakage after long periods of indwellmay result.

One preferred method of applying bonding agent to the housing 102 suchthat the upper landing 117 and exterior surface 112 receive such agentwhile minimizing migration to the interior of the housing is minimizedis by placing the housing 102 is a vertical position with the upper edge116 facing downwards. Bonding agent is applied, preferably by injection,to the exterior surface 112 and gravity causes the agent to flow downand wet the landing 117. Gravity also hinders any migration of thebonding agent into the interior surface of the housing 102. A furtherpreferred step includes inserting the upper end portion 110 of thehousing 102 into a chamber (not shown) and applying a negative airpressure below the housing 102 such that air flows downward along thehousing which also hinders migration of the bonding agent upwards intothe interior of the housing.

It has been found that a UV curing adhesive, such as Loctite 3011, 3311and 3301 from Loctite Corporation of Rocky Hill, Conn. may be utilizedas a suitable bonding agent for any of the connectors 10, 100, 200.

The bonding agent should be cured for a sufficiently long period oftime.

Referring to FIGS. 4 and 6, to provide for threaded engagement with thelocking flange 20, threads 90 extend along a portion of the exteriorsurface 112. The upper end 127 of the threads 90 are spaced from theupper edge 116 of the housing 102 to form a surface 124 free of threads,ridges or the like to facilitate the bonding of the skirt 108 to thesurface 124. In a preferred embodiment the surface 124 is also formedwith very little if any draft or taper so that the skirt 108 does notcreep upward during setting of the bond between the valve 104 andhousing 102. Preferably the skirt 108 extends downward along the housing124 for a length L5 of about 0.07 to 0.08 inches

Referring also to FIG. 2, to minimize shredding of a lower edge 126 ofthe skirt 108 by the threads 64 on the locking flange 20 during removalof the penetrating member 12 it is important that such threads do notcatch on the edge 126. Thus it is desired that the lower edge 126 beseparated from the upper edge 127 of the threads 90 such that the widthof a defined gap 128 is less than the width of the threads 64.

To facilitate a releasable engagement of the penetrating member 12 tothe connector 100 and to minimize or eliminate any shredding of theskirt 108, the skirt 108 may be provided with a thickness such thatthere is minimal interference between the skirt 108 and the inner edgesurfaces 64 a of the threads 64 on the locking flange 20. However thesmaller the diameter defined by the skirt 108 with a given skirtthickness and housing thickness, the smaller the volume which mustaccommodate both the penetrating member 12 and valve 104 upon insertionof the member 12.

It has been found that providing a housing 102 with the upper portion110 having a external diameter of 0.25 inches and defining an opening144 with a diameter of 0.22 is desired to provide the proper clearancebetween the skirt 108 and locking flange 20 of an ISO standard luerconnection and yet also provide a housing with sufficient wall strengthto resist fracture and provide sufficient space for the displaced septum28 and luer tip 18 when the luer tip is inserted into the housing 102.

Referring to FIG. 4 in conjunction with FIG. 2, the frustoconical shapeof an ISO standard luer tip defines a diameter ranging from 0.155 in. to0.175 inches. Thus when an ISO standard luer tip 18 is inserted thedesired insertion distance D, it would be expected that the tip andhousing 102 define a clearance therebetween of 0.031 to 0.021 inches.What is surprising is that upon insertion of a male luer tip 18, thevalve 102 having an upper portion 38 with a thickness of about 0.055inches extends about the luer tip and is compressed within the smallerclearance without requiring an unacceptable insertion force. Inaddition, although one may expect some compression set of the septum 28due to the compression between the tip and housing which would lead toleakage after long indwell problems, it has been unexpectedly found thatthe valve member 104 maintains an adequate leak pressure after longperiods of indwell.

As illustrated in FIG. 7, the displacement and compression of the septum28 into the space between the tip 18 and housing 102 during insertion ofthe tip substantially fills the space between the lower portion 40 andhousing 102 for a depth corresponding to the majority of the extendedlength of the lower portion about the tip 18. The compressed septum 28displaces or flushes any fluid that has collected in this space. Theinjection of the fluid from the tip 18 into the interior of the housing102 flushes any remaining spaces within the housing. Thus stagnantpockets of fluid are avoided. The filling of the passageway 36 with thetip 18 and displaced septum 104 also reduces priming volume to a lowlevel.

Referring to FIG. 7, an embodiment of the needleless connector of thepresent invention is generally illustrated at 130. In particular theconnector 130 is shown as forming part of a Y-site connection assembly86. As is generally known in the field, Y-site connection assemblies 86are particularly suited for adding supplemental fluid to a flow of fluidalong a primary flow path 132 extending from an upper or entry section134 of attached tubing, through the Y-site assembly 86 and out along alower or exit section 136 of attached tubing.

The needless connector 130 is shown as generally corresponding to thesecond embodiment of the needless connector 100, however, the resealablevalve member 140 and housing 138 proximate the valve member may beshaped to correspond to the housing and valve member of either the firstembodiment 10, second embodiment 100 or the later described embodiment200.

As can be appreciated, once the luer tip 18 penetrates the valve member140, the passageway 66 in the tip is placed directly in fluidcommunication with that portion of the primary flow path 132 extendinginto the exit section 136 without any intermediate valves so any flowrestriction is reduced.

Referring to FIG. 8, a third embodiment of the needless connector of thepresent invention which is preferred, is generally indicated at 200. Thethird embodiment 200 has a housing 202 and includes the resealable valvemember 104 described in relation to the second embodiment 100. Thehousing 202 is similar to the first embodiment 100 except that a housingportion 204 below the gap 128 has been altered so that connector 200provides a higher removal resistance torque. Elements in the thirdembodiment 100 corresponding to elements in the first or secondembodiment are labeled with the same reference number.

In particular, the housing 202 indudes the upper portion 110 having thesurface 124 of a generally constant outside diameter over which theskirt 108 extends. A middle portion 206 extends downward from the upperportion 116 and a lower portion 208 extends downward from the middleportion. The lower portion 208 preferably defines a generally constantdiameter greater than the diameter defined by the upper portion 116. Themiddle portion 206 is formed to provide a transition from the upperportion 116 to the relatively wider lower portion 208. Preferably themiddle portion 206 is frustoconically shaped.

Referring to FIGS. 2 and 8, the housing 202 defines a set of doublestart threads 210 which extend downward along the housing about themiddle portion 206 and lower portion 208. In the preferredconfiguration, the threads 210 define a constant major diameter as thethreads extend along the lower and middle portions such that the heightof the threads decreases as the threads move downward along the middleportion. However the diameter defined by the lower portion 208 isgreater than the minor diameter defined by the internal threads 64 onthe locking flange 20 such that there is a sliding frictional engagementbetween the threads 64 and middle and lower portions 206, 208. Thefrictional engagement allows the connector 200 to provide an acceptableremoval resistance torque for an attached luer lock when the tip 18 haspenetrated to the desired insertion depth D.

Utilization of an upper portion with a surrounding skirt 108 defining adiameter approximately that of the standard major diameter of threads64, a frustoconical middle portion 206 defining a diameter increasingfrom a diameter less than the diameter defined by the skirt 108 to thediameter of the lower portion 208 and the lower portion defining adiameter greater than the minor diameter of the internal threads 64imparts a feel to the user similar to connecting to a standard femaleluer connection.

When the user first inserts the locking flange 20 over the connector200, slipping the flange over the upper portion 116 and surroundingskirt 108 promotes centering of the luer tip 18 relative to theconnector 200 and minimizes the opportunity for cross threading. As thetip and flange 20 continue over the connector 200, the threads 64 thenengage the threads 210 and the connector 200 must then be rotatedrelative to the flange 20 to threadingly engage the flange 20 to theconnector 200.

During rotation, the tip 18 extends through the opening 44 and rubsagainst the valve 104 however such contact supplies very littleresistance to turning. The threads 64 engage the middle portion 206 anda sliding frictional engagement begins and the required torque toadvance or unthread slowly increases as the tip ;is rotatably advanced.The threads 64 then engage the lower portion 208 having a constantdiameter which slows down the rate or increase in the removal torquebefore an unacceptable removal torque is achieved which may cause thelocking flange 20 to lock up on the connector.

In addition male luer locks 13 may be made of many different types ofmaterials which range in stiffness. It is important that the connectionof the connector 200 to the luer lock not place such a stress on thelocking flange 20 which may fracture the flange. The use of the lowerportion 208 with a constant diameter also accommodates luer locks ofvarious materials while preventing overstressing of the locking flange20.

Thus five example embodiments of a needleless connector have beendescribed. It is believed that the embodiments provide features whichsolve many of the drawbacks which have hindered widespread acceptance ofsuch needleless connectors relative to the market acceptance of the typeof connectors which must be pierced with a sharp needle or bluntcannula.

Referring to FIG. 9, an alternate embodiment of the connector uniquelysuited to handling higher leak pressures is generally indicated at 300.The connector 300 includes an elastic resealable member 301 such as aseptum 302 attached to a housing 304. The septum 302 includes agenerally disk shaped upper portion 306 and a generally tubularextension 308 depending downward within a passageway 310 formed by thehousing 304. The extension 308 is attached to the housing 304 to form asealed conduit 314 for the transmission of fluids injected through anopening 316, preferably a slit 318, extending through the upper portion306.

Referring briefly to FIG. 1 also, in a manner similar to the septum 28,the opening 316 may extend partially through the septum 302 with theanticipation that the opening will extend completely through the septumupon penetration by the luer tip 18. In addition, the upper portion 306may be formed in a manner similar to the upper portion 38 of septum 28.

A valve element, generally indicated at 320, provides at least one sealagainst pressurized fluid within an exit passageway 324 formed byportions of the extension 308 and housing 304. The exit passageway 324is in fluid communication with a device 326 in fluid communication witha body. The device 326 may include a catheter or an I.V. administrationset. If the connector 300 is for providing a resealable connection withan I.V. administration set, the housing 304 will preferably form aportion of a Y-site.

The valve 320 includes a pincher portion 328 which pinchingly deformsthe extension 308 to seal against leak pressure found in the exitpassageway 324. The pincher portion 328 is attached to the housing 304by fixedly clamping a peripheral edge 330 between an upper housing piece334 and a lower housing piece 336 which are bonded together to form thehousing 304.

The connector 300 also includes an extension collapsing element 338which contacts and partially collapses a portion of the extension 308after and possibly during the sealing of the extension by the valve 320.The partial collapsing produces an expelling of fluid from the exitpassageway 324 after the sealing of the extension by the valve 320.

Referring also to FIG. 5, in the preferred embodiment, the collapsingelement 338 is connected to, by being integrally formed as a portion of,the valve 320. The collapsing element 338 includes two legs 340connected to and extending downward and outward from the pincher portion328. The legs 340 extend on opposite sides of the extension 338 andcontact the extension deforming the extension radially inward. When aluer tip 18 penetrates the septum 302 by extending through the opening316, to the desired depth D, the tip contacts the pincher portion 328displacing it downward and opening the element to place the passageway66 in fluid communication with the exit passageway 324. The legs 340 arealso forced radially outward against the housing 304 allowing theextension 308 to expand. During removal of the tip 18, the pincherportion 328 of the valve 320 closes, initially sealing the extension308, and then the legs 340 continue to collapse the extension 308 belowthe pincher portion forcing a portion of the fluid out of the exitpassageway 324 into the device 326.

To place the pincher portion 328 in a better position for contact andactivation by the luer tip 18, the valve 320 may be formed with acentral portion 344 offset upward of the peripheral edge 330. The legs340 are attached to this central portion 344; however, the legs may beattached to other parts of the housing 304.

To facilitate sealingly attaching the extension 308 to the housing 306,the lower piece 336 forms a radial lip 346, and the lower end of theextension is adhesively attached to the housing 305 proximate this lip.To hinder buckling of the extension 308 when the luer tip 18 forces thecentral part of the septum 302 downward, the extension may be stretchedduring assembly and attached to the housing in the stretchedconfiguration.

Referring briefly to FIGS. 1 and 4, in a manner similar to the connector10, the septum 302 of the connector 300 may include an annular skirt 348and radial lip 350 which are bonded to the housing 304.

The attachment of the extension 308 to the upper portion 306 of theseptum 302 and the housing 304 may help support the upper portion 306against leaking due to pressurized fluid in the conduit 314. Theextension 308 also prevents fluids from flowing into the housing outsideof the extension an into areas which may be difficult to flush duringuse of the connector 300.

The septum 302 may also include a lower portion (not shown) similar tolower portion 40 (FIG. 3), but preferably the valve 320 provides most ofthe seal against leakage due to the pressure of fluid in the exitpassageway 324.

Referring to FIGS. 11 and 12, a further alternate embodiment of aconnector uniquely suited to providing a flow of fluid into the device326 after removal of the tip 18 is generally indicated at 200. Referringalso to FIG. 1, the connector 200 includes a resealable member 201,preferably a septum 202 having an upper portion 204 similar inconstruction to upper portion 38, an annular skirt 206 similar inconstruction to the annular skirt 52, and a lower portion 208 andopening 210 similar in construction to the lower portion 40 and opening44, respectively. The lower portion 208 is shown having a V shaped crosssection; however, other configurations such as the configuration oflower portion 40 are also acceptable.

The septum 202 is attached to the top end 212 of housing 214 to seal anopening 216 formed by the top end. The housing forms an internal chamber218 and a radially extending valve seat 220. A lower end 224 of thehousing 214 is adapted to form a luer connection with the device 326which is adapted to be placed in fluid communication with the body.

The septum 202 also includes a downward depending generally tubularextension 228 which extends to a point in reasonably close proximitywith the valve seat 220. Sealingly attached to a lower end 230 of theextension 228 is a radial sealing flange 234. The flange 234 extendsradially outward and forms a peripheral edge 236 which sealinglyattaches to the housing 214. The septum 202 and flange 234 cooperate toprevent fluid flowing through a passageway 238 formed within theextension 228 from flowing into the chamber 218 outside of the extensionand between the flange 234 and top end 240 of the housing.

Disposed within the housing 214 and about an outlet 240 of the chamber218 is a valve 248. The valve 248 is uniquely configured to provide lessfluid flow resistance when low pressure fluid is within the passageway238 and high fluid flow resistance when high pressure fluid is withinthe passageway. Referring to FIGS. 6 and 7, the valve includes a radialsealing flange 250 having a peripheral portion 254 extending over thevalve seat 220.

The valve 248 includes a set of downward depending legs 256 whichcontact a radial ledge 258 formed by the housing 214. The legs 256 areconfigured to support the flange 250 so that the peripheral edge 236 isspaced from the valve seat 220. Thus fluid may flow from the passageway238 around the peripheral edge 254 and out an outlet 260 for theconnector 200. The legs 256 are also configured to flex when fluid overa certain pressure is injected through the opening 210 and into thepassageway 238 (as particularly illustrated in FIG. 12), the pressure ofthe fluid and the action of the fluid flowing around the peripheralportion 254 flexes the legs 256 and the flange 250 moves downward toseal against the valve seat 220.

The valve 248 also includes a capillary tube 262, preferably of a smalldiameter and constructed of metal, glass or the like, which extendsthrough the flange 250 to form a passageway for a small flow of fluidfrom the passageway 238 into the outlet 260. The tube 262 is preferablysized so that the flow of fluid through the passageway is enough tomaintain a KVO or keep vein open flow of fluid to the device 326.

Also when the luer tip 18 is inserted through the opening 210 and fluidis injected into the extension 228, the extension elastically expands ina radial direction to form a reservoir 268. The resiliency of theextension 228 maintains the fluid at a pressure sufficient to keep theflange 250 sealed against the seat 220 so that fluid only flows throughthe capillary tube 262. When sufficient fluid flows out of the reservoir268 so that the extension 228 is in an almost deflated configuration,the pressure of the fluid in the passageway 238 drops to a level wherebythe legs 256 straighten and the flange 250 separates from the valve seat220 to allow much greater flow into the outlet 260.

Therefore it may be seen that by varying the configuration and materialof the legs 256 in conjunction with the material of the extension 228,the pressure at which the valve 248 opens may be altered.

Referring to FIG. 13 a further alternate embodiment of the needlessconnector is generally indicated at 400. The connector 400 includes anelastic, resilient, resealable valve 402 having an upper portion 404,middle portion 406 and annular skirt 408 similar in configuration to theupper portion 38, lower portion 40 and annular skirt 108, respectivelyof connector 200 (FIG. 8). In addition the valve 402 includes aconically shaped tubular lower portion 410 integrally attached to themiddle portion 406 such that an opening 414, preferably a slit, extendsdownward through the upper portion 404 and middle portion 404 into achamber 416 defined in part by the lower portion 410.

A lower edge 417 of the lower portion 410 is sealingly engaged to ahousing 418, preferably rigid, of the connector 400. In particular thehousing 418 includes an upper portion 420 similar in configuration tothe upper end of connector (FIG. 8) to supply the desired removal torqueresistance capabilities. The housing also includes a lower portion 424having a lower end 426 configured to establish a connection to a medicaldevice (not shown) such as a catheter 15 (FIG. 1).

The lower edge 417 of the lower portion 410 extends about and isattached to an upwardly extending nipple 428. A collar 430 formed by thelower portion 424 of the housing 418 extends about the lower edge 417and clamps the lower edge to the nipple 428. The lower portion 424 andupper portion 420 are attached to each other preferably by sonic weldingor other appropriate type.

Referring to FIGS. 13 and 14, the connector 400 is particularly suitedto eliminating voids and minimizing priming volume as the flow path iswithin the lower portion 410 of the valve 402 and fluid cannot flow intothe space between the valve and upper housing. In addition, byappropriately dimensioning the valve 402, the chamber 416 defined by thelower portion 410 when no luer tip 18 is inserted into the connector400, defines a volume which is less than the chamber 416′ defined by thelower portion 410 when the luer tip is inserted. Thus siphoning of fluidinto the chamber 416 upon removal of the tip 18 is avoided. Instead aslight flow of fluid from the chamber 416′ through the lower end of thevalve 426 upon removal of the tip 18 may occur.

Referring to FIGS. 15 and 16 a needleless connector particularly suitedto preventing siphoning upon removal of a luer tip 18 is generallyindicated at 450. Preferably the connector 450 is similar to theconnector 400 (FIG. 13) and elements in the connector 450 correspondingto elements in the connector 400 are labeled with the same referencenumber.

However connector 450 also includes a collapsing member 452, preferablya split collar 454 which is disposed in the void 456 between the lowerportion 410 of the valve 402 and the upper portion 420 of the housing418. The collapsing member 452 includes opposing inward landings 458disposed on opposite sides of the lower portion 410 and engaging thelower portion to collapse the lower portion thereby lowering the volumeof a chamber 460 defined by the lower portion. The landings 458 areresiliently supported by legs 464 angled in an outward direction. Thecollapsing member 452 may be composed of metal or other material whichprovides the desired resiliency in the legs 464.

Upon insertion of the luer tip 18, the luer tip 18 forces the landings458 outward, bending the legs 464 so that the legs become generallyaligned with the landings 458 and the lower portion 410 below the tip 18defines the chamber 460′. Fluid may then be injected into the connector.Upon removal of the tip 18, the resiliency of the lower portion 410 willcause the lower portion to seek to assume the conical shape; however,the legs 464 will force the landings 458 inward to further collapse thelower portion such that the chamber 460 defined by the lower portion hasa smaller volume than chamber 460′. Thus siphoning of fluid into thechamber 460 upon removal of the tip 18 is avoided and a slight volume offluid is expelled from the chamber 460′ through the lower end 426 uponthe tip removal.

It will be understood that the embodiments of the present inventionwhich have been described are illustrative of some of the applicationsof the principles of the present invention. Various modifications may bemade by those skilled in the art without departing from the true spiritand scope of the invention.

What is claimed is:
 1. A connector device for establishing a sealedconnection with a male luer assembly configured to conform to ISOstandards, said assembly including a male luer tip, said male luer tipencircled by an annular locking flange, said male leur tip and saidflange defining a generally cylindrical space between said flange andsaid tip, said connector device comprising: a housing forming an upperend opening and a central first passageway sized to receive the maleluer tip, said housing having an upper end portion configured to fitwithin the space defined by the male luer assembly when the male luertip is inserted downward into said opening, said first centralpassageway extending from said opening in a downward direction withinsaid housing, said housing including a first upper edge portion havingan outside surface of generally constant first diameter, and a secondlower portion spaced from said upper edge portion and having an outsidesurface of a generally constant second diameter, said second diameterbeing larger than said first diameter, said housing including a thirdintermediate portion extending from said distal edge portion to saidsecond portion, said third portion having an outside surface with achanging diameter; a resealable valve resiliently restrained relative tosaid housing, said valve including a first portion configured to sealsaid opening prior to insertion of said tip and having an upper surfaceradially extending across said opening, said upper surface beingdisposed and shaped to be easily wipeable, a second extension portionintegral with said first portion and extending generally verticallydownward within said passageway from a lower surface of said firstportion, said valve having a third extension portion attached to one ofsaid extension portion and a lower surface of said radial portion andextending downward, a lower end portion of said extension portionattached to said housing to form a sealed second passageway within saidsaid extension portion, said extension portion and said housing defininga generally annular space between said extension portion and saidhousing; and an opening formed in said valve such that when the luer tipis inserted downward into said opening in said housing and through saidseptum said first portion and said second portion elastically extendabout the luer tip and form a seal about said luer tip and allow fluidto be injected from said tip into said second passageway, the attachmentof said lower end of portion of said extension portion to said housingbeing such that fluid injected into said second passageway flows throughsaid housing without flowing into said annular space.
 2. The connectordevice of claim 1 wherein said valve includes a septum having an annularskirt attached to said first portion, said skirt extending over andattached to an outside surface of said housing proximate said opening.3. The connector device of claim 2 wherein said septum includes anannular channel formed by said skirt and said first portion, a distaledge portion of said housing received in said channel.
 4. The connectordevice of claim 3 wherein said distal edge portion forms a distallanding received in said channel, at least a portion of said distallanding being attached to said septum.
 5. The connector of claim 4wherein the entire length of said landing is attached to said septum. 6.The connector device of claim 5 wherein said connector includes abonding agent to attach said outside surface of said housing and saidlanding to said septum.
 7. The connector device of claim 1 wherein saidsecond portion of said resealable valve is formed with a generallyrectangular cross section in the proximate direction.
 8. The connectordevice of claim 1 wherein said valve includes a septum having an annularskirt attached to said first portion, said skirt extending over andattached to an outside surface of said housing proximate said opening.9. A connector device for establishing a sealed connection with a maleluer assembly configured to conform to ISO standards, said assemblyincluding a male luer tip and having a generally annular flange disposedgenerally about said male luer tip and defining a generally cylindricalspace between said flange and said tip, said connector devicecomprising: a housing forming an upper opening and a central firstpassageway sized to receive the male luer tip, said housing having anupper end portion configured to fit within the generally cylindricalspace defined by the male luer assembly when the male luer tip isinserted downward into said opening, said first central passagewayextending from said opening in a downward direction within said housing;a resealable valve resiliently restrained relative to said housing, saidvalve including, a first portion configured to seal said opening priorto insertion of said tip and having an upper surface radially extendingacross said opening, said upper surface being disposed and shaped to beeasily wipeable, a second portion integral with said first portion andextending generally vertically downward within said passageway from alower surface of said first portion, and a third extension portionattached to said lower surface of said first portion and extendingdownward, a lower end portion of said third portion attached to saidhousing to form a sealed second passageway within said extensionportion, said second portion extending within said second sealedpassageway portion, said third extension portion and said housingdefining a generally annular space between said extension portion andsaid housing; and an opening formed in said valve such that when theluer tip is inserted downward into said opening in said housing andthrough said septum said first portion and said second portionelastically extend about the luer tip and form a seal about said luertip and allow fluid to be injected from said tip into said secondpassageway, the attachment of said lower end of portion of saidextension portion to said housing being such that fluid injected intosaid second passageway flows through said housing without flowing intosaid annular space.
 10. The connector device of claim 9 wherein saidseptum includes an annular channel formed by said skirt and said firstportion, a distal edge portion of said housing received in said channel.11. The connector device of claim 10 wherein said distal edge portionforms a distal landing received in said channel, at least a portion ofsaid distal landing being attached to said septum.
 12. The connector ofclaim 11 wherein the entire length of said landing is attached to saidseptum.
 13. The connector device of claim 12 wherein said connectorincludes a bonding agent to attach said outside surface of said housingand said landing to said septum.
 14. The connector device of claim 13wherein said second portion of said resealable valve is formed with agenerally rectangular cross section in the proximate direction.